Community Home-based Care Intervention and Its Health Outcome in HIV-positive People (HIV)
|ClinicalTrials.gov Identifier: NCT03505866|
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : April 24, 2018
Integrated Development Foundation Nepal
Information provided by (Responsible Party):
Khem Narayan Pokhrel, Integrated Development Foundation Nepal
An intervention study was designed to examine the impact of impact of community home-based care intervention on mental health and treatment outcome in HIV-positive people. The intervention comprised a home-based counseling on anti-retroviral therapy (ART) adherence, psycho social support, basic health care services at the home of HIV-positive people. The intervention started in March, 2018 and completed in August 2018. The major measurements of the interventions were ART adherence, status of depression, anxiety, and stress levels.
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus Depression Stress Anxiety Quality of Life||Behavioral: Community home-based care intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||720 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The intervention was started in February and March, 2015 and was completed six month later. The program comprises of psychosocial support/peer counseling, ART adherence support and counseling, basic health care, and referral for further care. The support team comprises of a community health worker, a trained HIV-positive person, and a social worker.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Investigating the Impact of Community Home-based Care Intervention on Mental Health Outcomes and Anti-retroviral Therapy Adherence in People Living With HIV|
|Actual Study Start Date :||March 1, 2015|
|Actual Primary Completion Date :||August 31, 2015|
|Actual Study Completion Date :||August 31, 2015|
Mutual support groups of HIV
HIV-positive people who did not enroll in a community home-based care intervention and receiving regular HIV services and support from mutual support groups of HIV
Behavioral: Community home-based care intervention
HIV-positive people who received community home-based care intervention on a monthly basis for six months after they enrolled in the program.
Primary Outcome Measures :
- Depression [ Time Frame: 6 months ]Depression was measured using a Center for Epidemiologic Studies Depression (CESD) scale. This scale consists of 20 items that are designed to measure the participant's experience of depressive symptoms in the past week of data collection. The total scores range from 0 to 60, and, a cut off point was set as scores ≥ 16 designating the occurrence of depressives symptoms.
- Anti-retroviral therapy non-adherence [ Time Frame: 6 months ]Adherence to anti-retroviral therapy was measured using AIDS Clinical Trial Group Questionnaires. The questionnaires are designed to measure non-adherence whether the HIV-positive person missed at least one dose of anti-retroviral therapy in the past month of the data collection. The questionnaire assess
- Anxiety [ Time Frame: 6 months ]Anxiety was measured anxiety using Composite International Diagnostic Interview Short-Form (CIDI-SF) the scale use nine screening stem questions that were designed to measure the episodes of anxiety and their control over their worries and anxious state.
- stress [ Time Frame: 6 months ]Stress was in the past month using the Perceived Stress Scale (PSS). It consists of 10 items with scores ranging from "0" (never) to 4 (very often). The total score ranges from 0-40. Higher stress scores indicate high level of stress.
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